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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01084070
Enrollment
336
Registered
2010-03-10
Start date
2010-03-31
Completion date
2011-09-30
Last updated
2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Care

Keywords

early feeding, postoperative care, emergency surgery

Brief summary

The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.

Interventions

Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet at will indicated.

They will have nasogastric tube and restriction of oral intake until the first sign of restoration of intestinal transit (first flatus or stool, whichever comes first). Since then withdrew nasogastric tube and liquid diet starts within 24 hours, then continues with soft diet.

Sponsors

Hospital General de Agudos Dr. Cosme Argerich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 14 years after abdominal emergency surgery.

Exclusion criteria

* Lack of consensus of the patient * Concurrent extra-abdominal surgery * Short bowel or other clear indication of parenteral nutrition * Inability to feed orally (eg, decreased level of consciousness) * Interventional procedure * Esophageal surgery * Reoperations * Pancreatitis

Design outcomes

Primary

MeasureTime frameDescription
Postoperative ComplicationsAt 30 days or at dischargeThe rate of postoperative complications according with Clavien-Dindo classification, defined as any deviation from the normal postoperative course.

Secondary

MeasureTime frameDescription
Gastrointestinal leaksAt 30 days or at dischargethe leak of luminal contents from a surgical join between two hollow viscera or from surgical repair of continuity solution. The luminal contents may emerge either through the wound or at the drain site, or they may collect near the anastomosis or rapair, causing fever, abscess, septicaemia, metabolic disturbance and/or multiple-organ failure. The escape of luminal contents intoan adjacent localised area, detected by imaging, in the absence of clinical symptoms and signs should be recorded as a subclinical leak
Time to resume bowel functionsAt 30 days or at dischargeTime from surgery to the first flatus or deposition, whatever occurs first
Oral diet intoleranceAt 30 days or at dischargeThe appearance of vomits or abdominal pain after diet
Postoperative hospital stayAt 90 daysPostoperative hospital stay

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026